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Vaginal Progesterone as a Treatment for Women Active Preterm Labor

NCT01206998 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-10-01

No results posted yet for this study

Summary

The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.

Conditions

  • Labor, Premature

Interventions

DRUG

Vaginal progesterone gel

Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone)

DRUG

Placebo vaginal gel

Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug

Sponsors & Collaborators

  • Juniper Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University of Rochester

    lead OTHER

Principal Investigators

  • Tulin Ozcan, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206998 on ClinicalTrials.gov